DeepRhythm Platform
MEDICALGORITHMICS S A · Model DeepRhythm Platform · UDI-DI 05903021560698
Description
The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Midmark Corporation | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| 2026-07-01 | Philips North America Llc | Device will intermittently provide inaccurate data related to native heart rate. |
| 2026-07-01 | Philips North America Llc | Device will intermittently provide inaccurate data related to native heart rate. |
| 2026-06-29 | GE Medical Systems Information Technologies Inc | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of |
| 2025-09-12 | Philips North America | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-09-12 | Philips North America | Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. |
| 2025-08-22 | GE Medical Systems, LLC | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible |
| 2025-03-24 | Baxter Healthcare Corporation | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batter |
| 2024-12-18 | Braemar Manufacturing, LLC | Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring se |
| 2024-10-11 | Baxter Healthcare Corporation | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System |
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